Open intervertebral spacer

ABSTRACT

Open chambered spacers, implanting tools and methods are provided. The spacers  500′  include a body  505′  having a wall  506′  which defines a chamber  530′  and an opening  531′  in communication with the chamber  530′ . In one embodiment the wall  506′  includes a pair of arms  520′, 521′  facing one another and forming a mouth  525′  to the chamber  530′ . Preferably, one of the arms  520′  is truncated relative to the other, forming a channel  526 . In one aspect the body  505′  does a bone dowel comprise an off-center plug from the diathesis of a long bone. The tools  800  include spacer engaging means for engaging a spacer and occlusion means for blocking an opening defined in the spacer. In some embodiments, the occlusion means  820  includes a plate  821  extendable from the housing  805 . In one specific embodiment the plate  821  defines a groove  822  which is disposed around a fastener  830  attached to the housing  805  so that the plate  821  is sliceable relative to the housing  805.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 10/699,175 filed Oct. 31, 2003 now U.S. Pat. No. 7,678,149,which is a continuation of U.S. patent application Ser. No. 10/035,074filed Dec. 28, 2001 and now issued as U.S. Pat. No. 6,695,882, which isa continuation of U.S. patent application Ser. No. 09/453,787 filed Dec.3, 1999 and now issued as U.S. Pat. No. 6,409,765, which is a divisionalof U.S. patent application Ser. No. 08/867,963 filed Jun. 3, 1997 andnow issued as U.S. Pat. No. 6,033,438, the contents of each applicationhereby incorporated by reference in their entirety.

FIELD OF THE INVENTION

The present invention broadly concerns arthrodesis for stabilizing thespine. More specifically, the invention provides open-chamberedintervertebral spacers, instruments for implanting the spacers andmethods for making and using the spacers.

BACKGROUND OF THE INVENTION

Intervertebral discs, located between the endplates of adjacentvertebrae, stabilize the spine, distribute forces between vertebrae andcushion vertebral bodies. A normal intervertebral disc includes asemi-gelatinous component, the nucleus pulposus, which is surrounded andconfined by an outer, fibrous ring called the annulus fibrosus. In ahealthy, undamaged spine, the annulus fibrosus prevents the nucleuspulposus from protruding outside the disc space.

Spinal discs may be displaced or damaged due to trauma, disease oraging. Disruption of the annulus fibrosus allows the nucleus pulposus toprotrude into the vertebral canal, a condition commonly referred to as aherniated or ruptured disc. The extruded nucleus pulposus may press on aspinal nerve, which may result in nerve damage, pain, numbness, muscleweakness and paralysis. Intervertebral discs may also deteriorate due tothe normal aging process or disease. As a disc dehydrates and hardens,the disc space height will be reduced leading to instability of thespine, decreased mobility and pain.

Sometimes the only relief from the symptoms of these conditions is adiscectomy, or surgical removal of a portion or all of an intervertebraldisc followed by fusion of the adjacent vertebrae. The removal of thedamaged or unhealthy disc will allow the disc space to collapse.Collapse of the disc space can cause instability of the spine, abnormaljoint mechanics, premature development of arthritis or nerve damage, inaddition to severe pain. Pain relief via discectomy and arthrodesisrequires preservation of the disc space and eventual fusion of theaffected motion segments.

Bone grafts are often used to fill the intervertebral space to preventdisc space collapse and promote fusion of the adjacent vertebrae acrossthe disc space. In early techniques, bone material was simply disposedbetween the adjacent vertebrae, typically at the posterior aspect of thevertebra, and the spinal column was stabilized by way of a plate or rodspanning the affected vertebrae. Once fusion occurred, the hardware usedto maintain the stability of the segment became superfluous and was apermanent foreign body. Moreover, the surgical procedures necessary toimplant a rod or plate to stabilize the level during fusion werefrequently lengthy and involved.

It was therefore determined that a more optimal solution to thestabilization of an excised disc space is to fuse the vertebrae betweentheir respective end plates, preferably without the need for anterior orposterior plating. There have been an extensive number of attempts todevelop an acceptable intradiscal implant that could be used to replacea damaged disc and maintain the stability of the disc interspace betweenthe adjacent vertebrae, at least until complete arthrodesis is achieved.The implant must provide temporary support and allow bone ingrowth.Success of the discectomy and fusion procedure requires the developmentof a contiguous growth of bone to create a solid mass because theimplant may not withstand the compressive loads on the spine for thelife of the patient.

Several metal spacers have been developed to fill the void formed and topromote fusion. Sofamor Danek Group, Inc., (1800 Pyramid Place, Memphis,Tenn. 38132, (800) 933-2635) markets a number of hollow spinal cages.For example, U.S. Pat. No. 5,015,247 to Michelson and U.S. Ser. No.08/411,017 to Zdeblick disclose a threaded spinal cage. The cages arehollow and can be filled with osteogenic material, such as autograft orallograft, prior to insertion into the intervertebral space. Aperturesdefined in the cage communicate with the hollow interior to provide apath for tissue growth between the vertebral endplates.

Although the metal fusion devices of Sofamor Danek and others are widelyand successfully employed for reliable fusions, it is sometimesdesirable to use an all-bone product. Bone provides many advantages foruse in fusions. It can be incorporated after fusion occurs and thereforewill not be a permanent implant. Bone allows excellent postoperativeimaging because it does not cause scattering like metallic implants.Stress shielding is avoided because bone grafts have a similar modulusof elasticity as the surrounding bone. Although an all-bone spacerprovides these and other benefits, the use of bone presents severalchallenges. Any spacer which will be placed within the intervertebraldisc space must withstand the cyclic loads of the spine. Cortical boneproducts may have sufficient compressive strength for such use, however,cortical bone will not promote rapid fusion. Cancellous bone is moreconducive to fusion but is not biomechanically sound as anintervertebral spacer.

Several bone dowel products such as the Cloward Dowel have beendeveloped over the years. Bone dowels in the shape of a generallycircular pin can be obtained by drilling an allogeneic or autogeneicplug from bone. As shown in FIGS. 1 and 2, the dowels 100, 200 have oneor two cortical surfaces 110 and an open, latticed body of brittlecancellous bone 120, 220 backing the cortical surface 210 or between thetwo cortical surfaces 110. The dowels 100, 200 also include a drilledand/or tapped instrument attachment hole 115, 215. Dowels and other boneproducts are available from the University of Florida Tissue Bank, Inc.,(1 Innovation Drive, Alachua, Fla. 32615, 904-462-3097 or 1-800-OAGRAFT;Product numbers 280012, 280014, and 280015).

While the bone dowels of the prior art are valuable bone graftingmaterials, these dowels have relatively poor biomechanical properties,in particular a low compressive strength. Accordingly, these dowels maynot be suitable as an intervertebral spacer without internal fixationdue to the risk of collapsing prior to fusion under the intense cyclicloads of the spine. A need remains for dowels having the advantages ofallograft but with even greater biomechanical strength.

In response to this need, the University of Florida Tissue Bank, Inc.,has developed a proprietary bone dowel machined from the diaphysis oflong bones. Referring now to FIG. 3, the dowel 300 includes a toolengagement end 301 and an opposite insertion end 302. Between the twoends 301 and 302, the dowel 300 includes a chamber 330 formed from thenaturally occurring medullary canal of the long bone and an opening 331in communication with the chamber 330. The chamber 330 can be packedwith an osteogenic material to promote fusion while the cortical body305 of the dowel 300 provides support. The dowels are also advantageousin that they provide desirable biomechanics and can be machined forvarious surface features such as threads or annular ribbing. In someembodiments, the outer cortical surface 310 of the tool engagement end301 is machined with an instrument attachment feature and an alignmentscore mark. As shown in FIG. 3, the insertion end 302 may include achamfered portion 340.

While these diaphysial cortical dowels are a major advance in thisfield, a need has remained for bone dowels and other intervertebralspacers with greater versatility.

SUMMARY OF THE INVENTION

This invention provides spacers having an open chamber, tools forimplanting the spacers and methods for making and using the spacers. Thespacers include a body having a wall which defines a chamber and anopening in communication with the chamber. In one aspect, a channel isdefined in the wall in communication with the chamber and the outersurface of the spacer. In another embodiment the wall includes a pair ofarms facing one another and forming a mouth to the chamber. In apreferred embodiment, one of the arms is truncated relative to theother. In some aspects, the body is composed of bone. In one aspect thebody is a dowel having a substantially C-shaped chamber and comprisingan off-center bone plug obtained from the diaphysis of a long bone.

Tools for implanting spacers are also provided. The tools include spacerengaging means for engaging a spacer and occlusion means for blocking anopening defined in the spacer. In one aspect the engaging means includesa shaft slidingly disposed within a housing and having a threaded postfor engaging a threaded tool hole in the spacer. In some embodiments,the occlusion means includes a plate extendable from the housing. In onespecific embodiment the plate defines a groove which is disposed arounda fastener attached to the housing so that the plate is slideablerelative to the housing.

This invention also includes methods for obtaining an open bone doweland methods for using the spacers of this invention. The methods ofmaking a dowel according to this invention include cutting an off-centerplug from the diaphysis of a long bone to obtain a bone dowel having anopen chamber. In one aspect, the dowel is machined to include desirablesurface features such as threads, grooves and instrument holes. In stillanother aspect, the methods include chamfering the forward end of thedowel. The methods for using the spacers of this invention includemaking a cavity between two vertebrae to be fused and implanting aspacer having an open chamber. In some embodiments the chamber is packedwith osteogenic material before the spacer is implanted. In otheraspects of the invention, osteogenic material is packed into and aroundthe chamber through the mouth or channel after implantation.

The combination of the open-chambered spacers of this invention with thetools and methods of this invention provide a versatile spacer withoutany compromise in biomechanical integrity. The spacers can be packedbefore or after implantation. This invention facilitates implanting apair of open spacers close to each other in an intervertebral space.Where the spacer is a bone dowel, the dowel can be formed with less bonethan is needed for conventional dowels, conserving precious bone stock.

Accordingly, it is one object of this invention to provide anopen-chambered fusion spacer and methods for using the spacer in anarthrodesis procedure.

Another object is to improve patient incidence of safe and satisfactoryspinal stabilization and fusion.

Another object of this invention is to provide a dowel for vertebralfusions which has improved biomechanical properties and versatility overstandard dowels known in the art.

Still another object of the present invention is to provide a spacerwith satisfactory biomechanical features and improved osteogenic andfusion promoting features.

These and other objects, advantages and features are accomplishedaccording to the spacers, tools and methods of the following descriptionof the preferred embodiments of the present invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a standard Cloward Dowel known in the art.

FIG. 2 shows a standard unicortical dowel known in the art.

FIG. 3 shows a diaphysial cortical dowel produced and sold by TheUniversity of Florida Tissue Bank, Inc.

FIG. 4 is a side perspective view of one embodiment of theopen-chambered spacer of this invention.

FIG. 4 a is a side perspective view of another embodiment of anopen-chambered spacer.

FIG. 5 is an end elevational view of the spacer of FIG. 4.

FIG. 6 is a top elevational view of a pair of open chambered dowels ofthis invention implanted within an intervertebral space.

FIG. 7 depicts the anatomy of a lumbar vertebral segment.

FIG. 8 is a top elevational view of a pair of open chambered dowels ofthis invention implanted within an intervertebral space via an anteriorsurgical approach.

FIG. 9 is a top elevational view of a pair of open chambered dowels ofthis invention implanted within an intervertebral space via a posteriorsurgical approach.

FIG. 10 is a side perspective view of one embodiment of an openchambered dowel having a truncated arm defining a channel to the mouthand chamber.

FIG. 11 is a top perspective view of an open chambered dowel with armsdefining concave faces.

FIG. 12 is a top perspective view of an open chambered bone dowel.

FIG. 13 is a side perspective view of one embodiment of this inventionin which the dowel is grooved.

FIG. 14 is a side perspective view of a threaded dowel of thisinvention.

FIG. 15 is a side cross-sectional view of a detail of a portion of thethreads of a spacer of this invention.

FIG. 16 shows various cuts across bone diaphysis and the resultingdowels formed according to this invention.

FIG. 17 is a top elevational view of one embodiment of a dowel threaderof this invention.

FIG. 18 is a side elevational view of the dowel threader of FIG. 17.

FIG. 19 is an end elevational view of the dowel threader of FIGS. 17 and18 showing elements of the cutter assembly.

FIG. 20 is a detailed view of a single tooth of one cutter blade of thedowel threader.

FIG. 21 is a global side view of a cutter blade.

FIG. 22 is a detailed side view of the cutter blade of FIG. 21.

FIG. 23 is a detailed side view of the cutter blade of FIGS. 21 and 22.

FIG. 24 is a top perspective view of one embodiment of an insertion toolof this invention.

FIG. 25 is a side perspective view of the tool of FIG. 24.

FIG. 26 is a perspective view of a spacer engaging element of aninsertion tool.

FIG. 27 is a perspective view of a spacer engaging element of aninsertion tool.

FIG. 28 is a side elevational view of an insertion tool engaged to aspacer.

FIG. 29 is a top perspective view of the view shown in FIG. 28.

FIG. 30 is an exploded side perspective view of a tool-spacer assemblyaccording to this invention.

FIG. 31 is a side perspective view of a tool-spacer assembly.

FIG. 32 is a top perspective view of a fastener of this invention.

FIG. 33 is a side elevational view of the fastener of FIG. 32.

FIG. 34 is a top elevational view of the fastener of FIGS. 32 and 33.

FIG. 35 is a top elevational view of a spacer according to one specificembodiment of this invention.

FIG. 36 is a side view of the spacer of FIG. 35.

FIG. 37 is a front perspective view of the spacer of FIG. 35.

FIG. 38 is a detail of a portion of the threaded surface of the spacerof FIG. 35.

FIG. 39 is a detail of one embodiment of the thread of one embodiment ofthe threaded dowel of this invention.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

For the purposes of promoting an understanding of the principles of theinvention, reference will now be made to the embodiments illustrated inthe drawings and specific language will be used to describe the same. Itwill nevertheless be understood that no limitation of the scope of theinvention is thereby intended, such alterations and furthermodifications in the illustrated device, and such further applicationsof the principles of the invention as illustrated therein beingcontemplated as would normally occur to one skilled in the art to whichthe invention relates.

This invention provides spacers having an open-mouthed chamber. Thesespacers are advantageous for maximum exposure of vertebral tissue toosteogenic material within the chamber and allow close placement of apair of spacers within the intervertebral space. The design of thesespacers conserve material without compromising biomechanical propertiesof the spacer. This is particularly advantageous when the material isbone because the invention preserves precious allograft. In fact, largerdowels and other shaped grafts can be obtained from smaller bones thanwas ever thought possible before the present invention. Likewise,smaller dowels having a pre-formed chamber may be efficiently obtainedfrom larger bones.

Although any open-chambered spacer is contemplated, in one embodimentthe spacers are obtained as an off-center transverse plug from thediaphysis of a long bone. This results in a dowel having an open-mouthedchamber. Because the long bone naturally includes the medullary canal, apre-formed chamber is inherently contained within the dowel. When theplug is cut off-center in a certain way, the dowel includes anopen-mouthed chamber. Surprisingly, the biomechanical properties ofthese dowels are not compromised by the absence of the missing chamberwall.

Referring now to FIGS. 4 and 5, one embodiment of an interbody fusionspacer of this invention is shown. The spacer 500 includes a body 505with a tool engagement end 501 and an opposite insertion end 502. Thebody 505 includes a wall 506 defining a chamber 530 between the two ends501, 502 and an opening 531 in communication with the chamber 530.Preferably, the insertion end 502 includes a solid protective wall 503which is positionable to protect the spinal cord from escape or leakageof osteogenic material from the chamber 530 when the spacer is placedvia an anterior approach.

As shown in FIG. 4, the chamber 530 is open in that it also communicateswith a further aperture such as a mouth or a channel. The aperture alsocommunicates with the outer surface 510 of the spacer 500, preferably atthe tool engagement end 501. The aperture can provide access to thechamber 530 after implantation or can facilitate insertion of the spacer530 into the intervertebral space. Comparing FIG. 4 with FIG. 3, it isevident that the chamber 530 is open so that the body 505 and chamber530 are substantially C-shaped as opposed to the defined chamber 330 ofFIG. 3. In some embodiments, including the one depicted in FIG. 4, theaperture is a mouth 525 formed by a pair of facing and opposing arms520, 521.

Bilateral placement of dowels 500 is preferred as shown in FIG. 6. Thisconfiguration provides a substantial quantity of bone graft availablefor the fusion. The dual bilateral cortical dowels 500 result in asignificant area of cortical bone for load bearing and long-termincorporation via creeping substitution, while giving substantial areafor placement of osteogenic autogenous bone which will facilitate boneybridging across the disc space. The dual dowel placement with facingchambers 530 results in an elongated compartment 540 that can be filledwith an osteogenic composition M. This provides for the placement of asignificant amount of osteogenic material as well as a large supportarea of cortical bone for load bearing.

The open spacers of this invention are advantageous because theycomplement the anatomy of the vertebrae V as shown in FIGS. 7-9. FIG. 7shows the variation in bone strength within the vertebral body V, withweaker bone W, disposed toward the center of the body B, and strongerbone S being disposed around the periphery, closest to the ringapophysis A. The open spacers of this invention are designed toaccommodate spinal anatomy. As shown in FIG. 8, two open spacers 500′can be implanted with the mouths 525′ facing to the center of theintervertebral space. This capitalizes on the load bearing capability ofthe stronger peripheral bone S of the vertebral body V by placing thestructural and load bearing portion of the spacer along the periphery ofthe body. At the same time, the osteogenic material M placed within thechambers is exposed to the more vascular center area W of the body.

In a preferred embodiment shown in FIG. 10, the first arm 520′ or thearm adjacent the tool engagement end 501′, is truncated relative to thesecond arm 521′. This forms a channel 526 from the outer surface 510′ tothe chamber 530′. Preferably and as shown in FIG. 10, the channel 526′is in communication with both the mouth 525′ and the chamber 530′although it is contemplated that the channel 526 could be provided in aclosed spacer having a chamber and an opening. In some embodiments, suchas the spacer 550 depicted in FIG. 11, the arms 580, 581 define concavefaces or surfaces 582 and 583. The concave faces 582 and 583 areconfigured to receive a complementary driving tool.

The channel 526 of this invention provides important advantages. Thechannel 526, particularly when formed as a truncated arm 520′ as shownin FIG. 10, facilitates implantation with an insertion tool. Because thetool can be placed within the channel during implantation, two spacersof this invention can be placed very closely together within theintervertebral space as shown in FIGS. 6 and 8. The tool need not extendbeyond the outer surface of the spacer. The channel 526 also allowsosteogenic material to be packed within the chamber and around thespacer after implantation. A further advantage of the channel is that,when it is formed in combination with the mouth of an open spacer, itallows the chamber of the spacer to be packed before implantation. Thetool may be placed within the channel to prevent escape of theosteogenic material from the chamber during implantation. The channel526 also provides access to the chamber 530′ for packing after thespacer 500′ is implanted into the disc space.

Referring now to FIG. 12, in a preferred embodiment, the spacer is adowel having a longitudinal axis A_(l) along a length L of the body 505.The open C-shaped chamber 530 is defined along a second axis A_(p)substantially perpendicular to the longitudinal axis A_(l). The body 505has an outer cross-section XS projected on a plane perpendicular to thelongitudinal axis A_(l) that is substantially uniform along the length Lof the body 505.

The spacers of this invention may be provided with surface featuresdefined in the outer surface 510. Where the spacer is a bone dowel asdescribed herein, the surface features can be machined into the corticalbone. Any desirable surface feature is contemplated. In one embodimentthe outer surface 510 of the tool engaging end 501 defines a toolengaging or instrument attachment hole 515 as shown in FIGS. 4 and 12.In a preferred embodiment, the hole 515 is threaded but any suitableconfiguration is contemplated. It is sometimes preferable that this end501 have a generally flat surface to accept the instrument for insertionof the dowel in the recipient.

In some embodiments, the spacer 500 includes an alignment score mark orgroove 516 defined in the tool engagement end 501. In FIG. 12 the groove516 is parallel to the axis A_(p) of the chamber 530 or perpendicular asshown in FIG. 4. The score mark may be widened to form a driver slot forreceiving an implantation tool. Alternatively, the end of the dowel maybe machined to exhibit a projection instead of a slot. Such a protrudingportion of bone may take a straight, flat-sided shape (essentially amirror image of the slot shown), it may be an elliptical eminence, abiconcave eminence, a square eminence, or any other protruding shapewhich provides sufficient end-cap or tool engaging end strength anddrive purchase to allow transmission of insertional torque withoutbreaking the dowel or the eminence. In other embodiments, a groove canbe omitted to enhance the strength of the tool engaging end 501.

Other surface features can be defined along the length L of the spacer.The surface features can provide engaging surfaces to facilitateengagement with the vertebrae and prevent slippage of the spacer as issometimes seen with a smooth graft. Referring now to FIG. 13, the spacer600 includes a groove or stop rib 632 inscribed along the circumferenceof the spacer. The rib 632 discourages backing out. In other preferredembodiments the outer surface 510′ of the dowel 500″ defines threads 542as shown in FIG. 14. The initial or starter thread 547 is adjacent theprotective wall 503′. As shown more clearly in FIG. 15, the threads 542are preferably uniformly machined threads which include teeth 543 havinga crest 544 between a leading flank 545 and an opposite trailing flank546. Preferably the crest 544 of each tooth 543 is flat. In one specificembodiment, the crest 544 of each tooth 543 has a width w of betweenabout 0.020 inches and about 0.030 inches. The threads 542 preferablydefine an angle a between the leading flank 545 and the trailing flank546 of adjacent ones of said teeth 543. The angle a is preferablybetween about 50 degrees and 70 degrees. Each tooth 543 preferably has aheight h′ which is about 0.030 inches and about 0.045 inches.

Machined surfaces, such as threads, provide several advantages that werepreviously only available with metal implants. Threads allow bettercontrol of spacer insertion than can be obtained with a smooth surface.This allows the surgeon to more accurately position the spacer and avoidover-insertion which is extremely important around the criticalneurological and vascular structures of the spinal column. Threads andthe like also provide increased surface area which facilitates theprocess of bone healing and creeping substitution for replacement of thedonor bone material and fusion. These features also increasepostoperative stability of the spacer by engaging the adjacent vertebralendplates and anchoring the spacer to prevent expulsion. Surfacefeatures also stabilize the bone-spacer interface and reduce micromotionto facilitate incorporation and fusion.

Various configurations of open-chambered spacers are contemplated bythis invention. When the spacer is obtained from the diaphysis of a longbone, the shape of the dowel is determined by the location of the cutinto the bone shaft. Referring now to FIG. 16, by appropriately locatingthe plug that is cut, “C”-shaped dowels of varying “C”-shaped cavitydepths and sidewall thicknesses are achievable. FIG. 16A shows the plugthat must be cut into the shaft to obtain a diaphysial cortical dowel300 (see FIG. 3) having a sidewall height H1 and a sidewall thicknessT1. FIGS. 16B-16D depict the off-center cuts required to generate“C”-shaped dowels of this invention having different sidewall heightsH2-H4 and sidewall thicknesses T2-T4. The sidewall thickness increasesfrom 16A to 16D, even though the diameter of the dowel is unchanged.

Surprisingly, we have found that the open chambered spacers of thisinvention have biomechanical properties similar to a spacer having adefined or closed chamber. For example, the open-chambered bone dowel500″ of FIG. 14 is no more susceptible to snapping or breakage duringmachining or implantation than the diaphysial cortical dowel 300 of FIG.3 having a full circular chamber. This strength is retained as long asthe thickness T4 of the wall 506′ at its narrowest aspect 570 ispreferably no less than about 5 mm.

As any of these open-chambered spacers are implanted and begin toexperience axial load, it is expected that the lower the sidewall heightH, the greater the load carried by the dowel end 501, 502. However,where the sidewall height H is approximately the same as the doweldiameter D, the sidewall 506 may carry a greater share of this axialload.

As illustrated in FIG. 4 a, in some embodiments, the wall 506 mayinclude upper and lower flattened portions 507, 508 to stabilize thedowel by neutralizing any rotational torque that may be induced bypressure on the sidewall. This could be achieved by reducing the heightH of the sidewall 506 and ends 501, 502 by filing or like means. Theseconsiderations may be less important for a threaded dowel than anon-threaded dowel as the threads tend to “bite” into the bone in whichthey are implanted, thereby preventing any rotation.

For cervical fusions, the dowel is preferably obtained from the fibula,radius, ulna or humerus. The dimensions of such dowels are typicallybetween about 8-15 mm in length or depth and about 10-14 mm in diameter.For thoracic and lumbar fusions, the dowel is preferably obtained fromthe humerus, femur or tibia. The dimensions of such dowels are typicallybetween about 10-30 mm in length and about 14-20 mm in diameter.

The chamber may be packed with any suitable osteogenic material. In apreferred embodiment, the osteogenic composition M has a length which isgreater than the length of the chamber 530 so that the osteogeniccomposition will contact the endplates of the adjacent vertebrae whenthe spacer 500 is implanted within the vertebrae. This provides bettercontact of the composition with the endplates to stimulate boneingrowth.

Any suitable osteogenic material or composition is contemplated,including autograft, allograft, xenograft, demineralized bone, syntheticand natural bone graft substitutes, such as bioceramics and polymers,and osteoinductive factors. The terms osteogenic material or osteogeniccomposition used here means virtually any material that promotes bonegrowth or healing including autograft, allograft, xenograft, bone graftsubstitutes and natural, synthetic and recombinant proteins, hormonesand the like.

Autograft can be harvested from locations such as the iliac crest usingdrills, gouges, curettes and trephines and other tools and methods whichare well known to surgeons in this field. Preferably, autograft isharvested from the iliac crest with a minimally invasive donor surgery.The osteogenic material may also include bone reamed away by the surgeonwhile preparing the end plates for the spacer.

Advantageously, where autograft is chosen as the osteogenic material,only a very small amount of bone material is needed to pack the chamber.The autograft itself is not required to provide structural support asthis is provided by the spacer. The donor surgery for such a smallamount of bone is less invasive and better tolerated by the patient.There is usually little need for muscle dissection in obtaining suchsmall amounts of bone. The present invention therefore eliminates orminimizes many of the disadvantages of employing autograft.

Natural and synthetic graft substitutes which replace the structure orfunction of bone are also contemplated for the osteogenic composition.Any such graft substitute is contemplated, including for example,demineralized bone matrix, mineral compositions and bioceramics. As isevident from a review of An Introduction to Bioceramics, edited by LarryL. Hench and June Wilson (World Scientific Publishing Co. Ptd. Ltd,1993, volume 1), there is a vast array of bioceramic materials,including BIOGLASS*, hydroxyapatite and calcium phosphate compositionsknown in the art which can be used to advantage for this purpose. Thatdisclosure is herein incorporated by reference for this purpose.Preferred calcium compositions include bioactive glasses, tricalciumphosphates and hydroxyapatites. In one embodiment, the graft substituteis a biphasic calcium phosphate ceramic including tricalcium phosphateand hydroxyapatite.

In some embodiments, the osteogenic compositions used in this inventioncomprise a therapeutically effective amount to stimulate or induce bonegrowth of a substantially pure bone inductive or growth factor orprotein in a pharmaceutically acceptable carrier. The preferredosteoinductive factors are the recombinant human bone morphogeneticproteins (rhBMPs) because they are available in unlimited supply and donot transmit infectious diseases. Most preferably, the bonemorphogenetic protein is a rhBMP-2, rhBMP-4 or heterodimers thereof.

Recombinant BMP-2 can be used at a concentration of about 0.4 mg/ml toabout 1.5 mg/ml, preferably near 1.5 mg/ml. However, any bonemorphogenetic protein is contemplated including bone morphogeneticproteins designated as BMP-1 through BMP-13. BMPs are available fromGenetics Institute, Inc., Cambridge, Mass. and may also be prepared byone skilled in the art as described in U.S. Pat. No. 5,187,076 to Wozneyet al.; U.S. Pat. No. 5,366,875 to Wozney et al.; U.S. Pat. No.4,877,864 to Wang et al.; U.S. Pat. No. 5,108,922 to Wang et al.; U.S.Pat. No. 5,116,738 to Wang et al.; U.S. Pat. No. 5,013,649 to Wang etal.; U.S. Pat. No. 5,106,748 to Wozney et al.; and PCT Patent Nos.WO93/00432 to Wozney et al.; WO94/26893 to Celeste et al.; andWO94/26892 to Celeste et al. All osteoinductive factors are contemplatedwhether obtained as above or isolated from bone. Methods for isolatingbone morphogenetic protein from bone are described in U.S. Pat. No.4,294,753 to Urist and Urist et al., 81 PNAS 371, 1984.

The choice of carrier material for the osteogenic composition is basedon biocompatibility, biodegradability, mechanical properties andinterface properties as well as the structure of the load bearingmember. The particular application of the compositions of the inventionwill define the appropriate formulation. Potential carriers includecalcium sulphates, polylactic acids, polyanhydrides, collagen, calciumphosphates, polymeric acrylic esters and demineralized bone. The carriermay be any suitable carrier capable of delivering the proteins. Mostpreferably, the carrier is capable of being eventually resorbed into thebody. One preferred carrier is an absorbable collagen sponge marketed byIntegra LifeSciences Corporation under the trade name Helistat*Absorbable Collagen Hemostatic Agent. Another preferred carrier is abiphasic calcium phosphate ceramic. Ceramic blocks are commerciallyavailable from Sofamor Danek Group, B. P. 4-62180 Rang-du-Fliers, Franceand Bioland, 132 Rou d Espangne, 31100 Toulouse, France. Theosteoinductive factor is introduced into the carrier in any suitablemanner. For example, the carrier may be soaked in a solution containingthe factor.

The present invention also provides methods for making the open spacersof this invention. In one embodiment, a method for making an openchambered bone dowel includes obtaining an off-center plug from thediaphysis of a long bone so that the dowel has an open chamber. The openchamber is preferably substantially concave or C-shaped and has an axisthat is substantially perpendicular to the long axis of the dowel.Appropriate human source bones include the femur, tibia, fibula,humerus, radius and ulna. Long bones from other species are alsocontemplated although human source bones are generally preferred forhuman recipients.

The first step is to identify an acceptable donor based upon appropriatestandards for the particular donor and recipient. For example, where thedonor is human, some form of consent such as a donor card or writtenconsent from the next of kin is required. Where the recipient is human,the donor must be screened for a wide variety of communicable diseasesand pathogens, including human immunodeficiency virus, cytomegalovirus,hepatitis B, hepatitis C and several other pathogens. These tests may beconducted by any of a number of means conventional in the art, includingbut not limited to ELISA assays, PCR assays, or hemagglutination. Suchtesting follows the requirements of: (i) American Association of TissueBanks, Technical Manual for Tissue Banking, TechnicalManual—Musculoskeletal Tissues, pages M19-M20; (ii) The Food and DrugAdministration, Interim Rule, Federal Register/Vol. 58, No. 238/Tuesday,Dec. 14, 1994/Rules and Regulations/65517, D. Infectious Disease Testingand Donor Screening; (iii) MMWR/Vol. 43/No. RR-8m Guidelines forPreventing Transmission of Human Immunodeficiency Virus ThroughTransplantation of Human Tissue and organs, pages 4-7; (iv) FloridaAdministrative Weekly, Vol. 10, No. 34, Aug. 21, 1992, 59A-1.001-01459A-1.005(12)(c), F.A.C., (12)(a)-(h), 59A-1.005 (15), F.A.C.,(4)(a)-(8). In addition to a battery of standard biomechanical assays,the donor, or their next of kin, is interviewed to ascertain whether thedonor engaged in any of a number of high risk behaviors such as havingmultiple sexual partners, suffering from hemophilia, engaging inintravenous drug use, etc. Once a donor has been ascertained to beacceptable, the bones useful for obtention of the dowels are recoveredand cleaned.

Preferably, the bone plugs are obtained using a diamond or hard metaltipped cutting bit which is water cleaned and cooled. Commerciallyavailable bits (e.g. core drills) having a generally circular nature andan internal vacant diameter between about 10 mm to about 20 mm areamenable to use for obtention of these bone plugs. Such core drills areavailable, for example, from Starlite, Inc. In one embodiment, apneumatic driven miniature lathe having a spring loaded carriage whichtravels parallel to the cutter is used. The lathe has a drive systemwhich is a pneumatic motor with a valve controller which allows adesired RPM to be set. The carriage rides on two runners which are 1.0inch stainless rods and has travel distance of approximately 8.0 inches.One runner has set pin holes on the running rod which will stop thecarriage from moving when the set pin is placed into the desired hole.The carriage is moveable from side to side with a knob which hasgraduations for positioning the graft. A vice on the carriage clamps thegraft and holds it in place while the dowel is being cut. The vice has acut-out area in the jaws to allow clearance for the cutter.

In operation, the carriage is manually pulled back and locked in placewith a set pin. The graft is loaded into the vice and is aligned withthe cutter. Sterile water is used to cool and remove debris from graftand/or dowel as the dowel is being cut. The water travels down throughthe center of the cutter to irrigate as well as clean the dowel underpressure. After the dowel is cut, sterile water is used to eject thedowel out of the cutter.

Dowels of any size can be prepared according to this invention. In someembodiments, the dowels range from 5 mm to 30 mm diameters with lengthsof about 8 mm to about 36 mm being generally acceptable, although otherappropriate gradations in length and diameter are available. Forcervical dowels, such as anterior cervical fusion or ACF dowels, lengthsof 8 mm, 9 mm, up to about 15 mm are generally desirable. Dowels ofdiffering diameter are most conveniently obtained as follows:

Diameter Source 10.6-11 mm fibula 12 mm radius 14 mm ulna 14+ mm smallhumeri

Dowels for thoracic and lumbar fusions, such as anterior thoracic innerbody fusion (ATIF) and anterior lumbar inner body fusion (ALIF) dowels,respectively, having a depth of between about 10-36 mm, and preferablybetween about 15-24 mm, are generally acceptable, depending on the needsof a particular patient. Dowels of differing diameter for thoracic andlumbar fusions are most conveniently obtained as follows:

Diameter Source 14-16 mm humerus 16-18 mm femur 18-20 mm tibia

While the foregoing diameters and source bones for such dowels is auseful guide, one of the significant advances provided by this inventionis that the open-chambered dowel of this invention provides tremendousflexibility with respect to the source bone used.

Since the spacers of the preferred embodiment are obtained fromoff-center transverse plugs across the diaphysis of long bones, eachdowel has the feature of having a substantially “C”-shaped chamberthrough the dowel perpendicular to the length of the dowel formed by theintersection of the natural intramedullary canal of the source bone andthe cutter blade as it forms the plug. The canal cavity in the long boneis, in vivo, filled with bone marrow. In the standard Cloward Dowel andunicortical dowels known in the art, no such natural cavity exists andthe cancellous bone that forms the body of such dowels tends to be toobrittle to accept machining of such a cavity. The dowels of thisinvention, by the nature of their origin, inherently define such acavity. Naturally, based on this disclosure, those skilled in the artwill recognize that other bone sources could be used which do not havethe intramedullary canal, and if sufficient strength is inherent to thebone, a cavity or chamber could be machined. In addition, it will beappreciated from the instant disclosure that an existing diaphysialcortical dowel (FIG. 3), available from the University of Florida TissueBank, Inc., could be modified by machining one side of such a doweluntil one wall of the dowel is sufficiently abraded to “break-through”,thereby transforming the diaphysial cortical dowel into the “C”-shapeddowel of this invention. Accordingly, such extensions of this inventionshould be considered as variants of the invention disclosed herein andtherefore come within the scope of the claims appended hereto.

The marrow is preferably removed from the intramedullary canal of thediaphysial plugs and the cavity is cleaned, leaving the chamber. Thespacer may be provided to the surgeon with the chamber prepacked orempty for the surgeon to pack during surgery. The cavity or chamber canthen be packed with an osteogenic material or composition.

The plug is then machined, preferably in a class 10 clean room to thedimensions desired. The machining is preferably conducted on a lathesuch as a jeweler's lathe, or machining tools may be specificallydesigned and adapted for this purpose. Specific tolerances for thedowels and reproducibility of the product dimensions are importantfeatures for the successful use of such dowels in the clinical setting.

In some embodiments, the forward end of the dowel which is to beinserted into a cavity formed between adjacent vertebrae is chamfered.The curvature of the chamfered end facilitates insertion of the dowelinto the intervertebral space. Chamfering can be accomplished byappropriate means such as by machining, filing, sanding or otherabrasive means. The tolerance for the chamfering is fairly liberal andthe desired object is merely to round or slightly point the end of thedowel that is to be inserted into the cavity formed between adjacentvertebrae to be fused.

In some embodiments, the invention includes methods for providingsurface features into the walls of the dowels. The methods may includedefining a tool or instrument attachment hole in an end of the dowel.The hole may be drilled and preferably tapped. Preferably, the dowelwill be of such dimensions as to fit standard insertion tools, such asthose produced by Sofamor Danek Group, Inc. (1800 Pyramid Place,Memphis, Tenn. 38132, (800) 933-2635). In addition, a score mark ordriver slot may be inscribed on the instrument attachment end of thedowel so that the surgeon can align the dowel so that the chamber isparallel with the length of the recipient's spinal column. The mark orslot allows the surgeon to orient the dowel properly after the dowel isinserted and the chamber is no longer visible. In the properorientation, the endplates of the adjacent vertebrae are exposed toosteogenic material in the chamber. In some embodiments, the driver slotis omitted to preserve as much bone stock, and therefore strength, inthe end as possible.

Surface features such as grooves and threads may be preferably definedor inscribed on the outer cylindrical surface of the dowel. Machining ofsuch features on dowels known in the art is difficult if not impossibledue to the brittle cancellous nature of such dowels. Accordingly, thedowels of this invention have the advantage of having very goodbiomechanical properties amenable to such machining.

Those skilled in the art will also recognize that any of a number ofdifferent means may be employed to produce the threaded or groovedembodiments of the dowel of this invention. However, one preferredembodiment of a thread cutter 400 is depicted in FIGS. 17-23. The cutter400 includes a drive shaft 402 for supporting a spacer and a cutterassembly 420. The terminal end 406 of the drive shaft 402 includes aspacer engager 407. In one embodiment and as best shown in FIG. 18, thespacer engager 407 is a protruding element which matingly corresponds tothe driver slot on the tool end of the open-chambered spacers of thisinvention. The drive shaft 402 can be turned to rotate and advance thespacer incrementally through the cutter assembly 420 to inscribe afeature such as a thread into the surface of the spacer.

In one embodiment, the drive shaft 402 can be turned by a handle 401rigidly attached to a first end 402 a of the shaft 402. The drive shaft402 preferably is provided with a graduated segment means for controlledincremental advancement of the drive shaft 402 upon rotation of thehandle 401. In this embodiment, the means is a threaded portion 403.Support means 404 and 405 are preferably provided for alignment andsupport of the shaft 402. Each of the support means 404, 405 include awall 404 a, 405 a defining an aperture 404 b, 405 b. The support means404, 405 may having controlling means within the apertures 404 b, 405 bfor controlling rotation and incremental advancement of the shaft. Insome embodiments, the controlling means include matching threads orbearings.

The thread cutter assembly includes a housing 408 and blades 421, 422and guide plates 424, 425 mounted within the housing 408. The cutterblades 421, 422 are held in place in the housing 408 by fixation wedges423 a and 423 b while guide plates 424 and 425, having no cutting teeth,are held in place by fixation wedges 423 c and 423 d. Fixation wedges423 a-d are held in place by screws 426 a-d. The foregoing arrangementis preferred, as it allows for easy assembly and disassembly of thecutter assembly, removal of the cutter blades, cleaning of the variouscomponents, and if desired, sterilization by autoclaving, chemical,irradiative, or like means. The cutter blades 421, 422 and guide plates424, 425 may be rigidly fixed in place by increasing the tension createdby tightening screws 426 a-d, which draws the fixation wedges 423 a-dinto the housing 408, thereby clamping these elements in place.Naturally, based on this disclosure, those skilled in the art will beable to develop equivalents of the cutter assembly system describedherein, such as by use of wing-nuts, welding or like means to affixthese various elements in appropriate cutting relationship to eachother.

Fixation wings 421 c and 421 d are provided to allow proper seating ofthe cutter blade upon insertion into the housing 408. At r a line isprovided on cutter blades 421 and 422, which allows for appropriateregistration between cutter blades 421 and 422 during manufacturethereof. Upon insertion into the housing 408, it is critical that theblades and the teeth thereon are appropriately registered so that asblade 421 cuts into the bone dowel as it is rotationally advancedthrough the cutter assembly 420, blade 422 is appropriately situated sothat its matching teeth are in phase with the thread inscribed by theteeth on blade 421. This is accomplished by a combination of thefixation wings 421 d and 421 c properly seating in the housing 408 suchthat wall 421 c abuts the housing 408 and the housing 408 walls abut theinsides of wings 421 d and 421 c.

The cutting edges 421 a, 422 a of the blades 421, 422 are disposed inrelation to each other so that they are on axis. The cutting edges 421a, 422 a and the guiding edges 424 a, 425 a of the guide plates definean aperture 427 for a spacer or dowel. The diameter of the dowel thatmay be threaded according to this device is defined by the diameter ofthe aperture 427.

The supports 404 and 405 and the housing 408 for the cutter assembly areall preferably mounted on a steady, solid, weighty base unit 409 viascrews, welding, or like attachment means at 410 a-f. The supports andthe cutter assembly are configured so that there is an appropriatetravel distance 411 from the fully backed out terminal end of the driveshaft 406 to the end of the cutter assembly 420. This distance must besufficient to allow insertion of a dowel blank and advancement of theblank through the cutter assembly 420 to allow a fully threaded dowel toemerge from the cutter assembly.

The cutter maintains true tooth form from top to bottom, so that thecutter can be sharpened by surface grinding the face. This is achievedby wire-cutting the teeth such that there is about a 5° incline 62 cbetween the descending vertices at the front and rear of each tooth, andabout an 8° incline 62 d between the front and rear of the top of eachtooth. This aspect can best be seen in FIG. 20. Also, the thickness ofthe cutter blade, 62 c, preferably about 0.100″ can be seen in thatfigure. The angle 61 in FIG. 20 is preferably about 60°. The width ofthe top of the tooth 62 b is preferably about 0.025″. The pitch 60 ispreferably about 0.100″. FIG. 21 shows an overall view of the cutterblades 421 or 422 which are assembled in the cutter assembly housing408. The entire length of the cutter blade 421 b is about 1.650″.

Details of the blades 421, 422 are shown in FIGS. 22 and 23. In thisembodiment, the cutter blade 421 has twelve cutting teeth 431-442. Thecutting edge 422 a has eleven teeth 451-461 spread over the length ofthe blade 422. At 451, the first tooth at 0.004″ in this example isencountered by the blank and at each successive tooth, an increase ofabout 0.004″ is made until the final tooth height of about 0.039 isreached at 460 and 461. As a dowel blank is fed into the cutterassembly, it first encounters a truncated tooth at 431, and at everysubsequent tooth, the height of the tooth is reached, in this example,of 0.039″ at 441 and 442. The truncated teeth 431-440 feed into thedowel being cut along the 300 line so that the teeth cut on only twosides. The dotted line 443 shows the final pitch and form that thecutter will cut in the bone dowel.

It will be recognized by those skilled in the art that all of theforegoing elements should preferably be manufactured from durablematerials such as 440 stainless steel, or like materials. In particular,the cutting surfaces 421 a and 422 a of the blades 421 and 422 are madefrom hard metal.

In operation, based on the foregoing description, it will be appreciatedthat the cutter blades 421 and 422 are placed into the housing 408,clamped into place via the fixation wedges 423 a, b and the screws 426a, b after the blades have been properly seated and the two blades areperfectly aligned. A blank dowel is then loaded into the orifice 427 andthe drive shaft with the protruding element 408 is inserted into a driveslot a dowel. As the handle 401 is turned, the drive shaft forces thedowel to rotate and advance incrementally through the cutter assembly420, thereby inscribing the thread defined by the cutter blades 421 and422 into the outer cylindrical surface or circumference of the dowel.

As noted above, those skilled in the art will recognize thatmodifications to the specifics of the device described will allow forthe preparation of the varied threads or grooves in the circumference ofthe dowel. For example, to form a groove in a dowel, the dowel could bemounted in a lathe, such as those known in the art and commerciallyavailable, for example from SHERLINE PRODUCTS, INC., SAN MARCOS, CALIF.92069, and a cutter blade applied as the dowel is rotated.

The final machined product may be stored, frozen or freeze-dried andvacuum sealed as known in the art for later use.

The spacers of this invention may be conveniently implanted with knowninstruments and tools. Any instrument which will firmly hold the implantand permit the implant to be inserted is contemplated. Preferably, theinstrument will be adapted to compensate for the open structure of thespacers of this invention.

The present invention further contemplates insertion devices forfacilitating the implantation of spacers, implants or bone graft. Thetools include spacer engaging means for engaging a spacer or other itemand occlusion means for blocking an opening defined in the spacer. Oneembodiment of an insertion tool of this invention is depicted in FIGS.24-26.

In one embodiment, an insertion tool 800 is provided which includes ahousing 805 having a proximal end 806 and an opposite distal end 807 anddefining a passageway 810 between the two ends. A shaft 815 which has afirst end 816 and an opposite second end 817 is disposed within thepassageway 810. The first end 816 of the shaft 815 is adjacent thedistal end 807 of the housing 805. The first end 816 defines a spacerengager 819. An occlusion member 820 is attached to the housing 805.

The spacer engager 819 has any configuration which will engage a spacer.In some embodiments the spacer engager 819 includes a post 818 as shownin FIG. 26 for engaging a hole in the spacer. The post 818 may have anyconfiguration which will provide for mating engagement with a hole in aspacer. For example, in preferred embodiments, the engager 819 isthreaded as shown in FIG. 26 to matingly engage a threaded tool hole.Other embodiments include sharply pointed tip 819 as shown in FIG. 24 ora hexagonal shaped tip 819″ (FIG. 27). In each case, the engager isshaped and sized to mate engagingly with the tool hole of the spacer. Inother embodiments, the spacer engaging means is a pair of prongs havingopposite facing spacer engaging members for grasping an outer surface ofthe spacer.

The spacer insertion tool 800 also includes an occlusion member 820 forblocking an opening defined in the spacer when the spacer engager 819 isengaged to the spacer. In a preferred embodiment, the occlusion member820 is extendable from the distal end 807 of the housing 805 forblocking an opening in the spacer. As shown in FIG. 28, the occlusionmember 820 closes the mouth 525′ and channel 526 defined in the spacer500′.

The occlusion member 820 is preferably slideably engaged to the housing805. Referring now to FIG. 29, in one embodiment, the occlusion member820 includes a plate 821 which defines a groove 822. A fastener 830 isengaged to a fastener bore 809 in the housing 805 and the groove 822 isdisposed around the fastener 830. In this way, the plate 821 isslideable relative to the housing 805.

As shown in FIG. 30, the housing 805 is preferably provided with arecess 808 which is defined to accept the occlusion member 820 withoutincreasing the effective diameter of the device 800. The occlusionmember is also adapted for the best fit with the spacer. For example,the interior surface 824 of the occlusion member would be curved tocomplement the scalloped faces 582 and 583 shown in FIG. 11 for crescentengagement. Referring now to FIGS. 30 and 31, the plate 821 of theocclusion member 820 preferably includes a curved superior surface 825which approximates and completes the minor diameter of the dowel 500′when the spacer engager 819 is engaged to the tool engaging hole 515′and the occlusion member 820 is blocking the channel 526 of the spacer500′. Preferably, the plate 821 and the arm 520′ of the spacer 500′ willbe configured such that the plate 821 will not extend beyond the channel526 when the tool 800 is engaged to the spacer 500′. In other words, thecurved superior surface 825 will not increase the effective rootdiameter RD of the threaded outer surface 510′. This facilitatesrotation and screw insertion of the spacer and occlusion membercombination into an intervertebral space.

The tool 800 depicted in FIG. 24 also includes a handle portion 840. Thehandle portion includes means for slidingly moving the shaft 815 withinthe housing 805 and for rotating the post 818. In the embodiment shownin FIGS. 24 and 25 the means includes a thumbwheel 841. In someembodiments, the handle portion 840 has a Hudson end attachment 842.

Referring now to FIGS. 32-34, the fastener 830 is preferably providedwith a housing engaging means shown in FIG. 32 as a post 834, and aplate engaging means or head portion 835. The fastener 830 preferablyincludes an internal hex 837 for receiving a fastener driving tool. Thepost portion 834 may be threaded for mating engagement with threadedbore 809 in the housing 805. In preferred embodiments shown in FIGS. 29and 30, the plate 821 defines a recess 826 surrounding the groove 822.The diameter d1 of the head portion 835 is greater than the diameter d2of the post 834. The diameter d2 is less than the width w1 of the groove822. The diameter d1 of the head portion is greater than width w1 butpreferably no greater than the distance w2 between the outer edges 827of the recess 826. Thus, the head portion 835 of the fastener 830 canrest on the recess 826 while the post portion 834 extends through thegroove 822. In this way, plate 821 is slidable relative to the housing805. This also provides for a low profile device which can be insertedinto various cannula for percutaneous procedures.

The spacers and tools in this invention can be conveniently incorporatedinto known surgical, preferably minimally invasive, procedures. Thespacers of this invention can be inserted using laparoscopic technologyas described in Sofamor Danek USA's Laparoscopic Bone Dowel SurgicalTechnique, =1995, 1800 Pyramid Place, Memphis, Tenn. 38132,1-800-933-2635, preferably in combination with the insertion tool 800 ofthis invention. Spacers of this invention can be convenientlyincorporated into Sofamor Danek's laparoscopic bone dowel system thatfacilitates anterior interbody fusions with an approach that is muchless surgically morbid than the standard open anterior retroperitonealapproaches. This system includes templates, trephines, dilators,reamers, ports and other devices required for laparoscopic dowelinsertion. Alternatively, a minimally invasive open anterior approachusing Sofamor Danek's open anterior bone dowel instrumentation or aposterior surgical approach using Sofamor Danke's posterior approachbone dowel instrumentation are contemplated.

The present invention also includes methods for fusing adjacentvertebrae. The spine may be approached from any direction indicated bythe circumstances. The vertebrae and the intervertebral space areprepared according to conventional procedures to receive the spacer. Aspacer of the appropriate dimensions is selected by the surgeon, basedon the size of the cavity created and the needs of the particularpatient undergoing the fusion. The spacer is mounted on an instrument,preferably via an instrument attachment hole. In one embodiment, anosteogenic material is placed within the chamber of the spacer and thechannel and or mouth of the spacer is then blocked with an occlusionmember of the instrument. The spacer is then inserted into the cavitycreated between the adjacent vertebra to be fused. The spacer isoriented within the intervertebral space so the osteogenic material inthe chamber is in communication with the end plates of the vertebra.Once the spacer is properly oriented within the intervertebral space,the occlusion member of the instrument can be withdrawn from the spaceraperture and the spacer engager is disengaged from the spacer.

In some embodiments, osteogenic material is packed into the chamberthrough the channel after implantation. In still other embodiments, asecond spacer is implanted into the intervertebral space. FIG. 8 depictsplacement of two dowels of this invention implanted from an anteriorapproach, while FIG. 9 shows bilateral placement of dowels from aposterior approach. In each case the channel 526 opens adjacent the toolengaging end 501′ allowing access to the chamber 530′ from either theanterior or posterior approach.

The combination of spacers of this invention with the tools of thisinvention allow the spacers to provide the benefits of an open spacerwithout suffering any biomechanical disadvantage or increased fiddlefactor. The occlusion member 825 blocks the mouth or channel to lessenthe stress on the wall of the spacer for smooth insertion. The occlusionmember also allows the chamber to be packed with osteogenic materialbefore the spacers are implanted. Once the spacer is implanted and theocclusion member is withdrawn, additional osteogenic material can bepacked into the chamber or around the spacers. In some procedures twoopen spacers are packed with the mouths facing one another as depictedin FIG. 8. The open mouth of the spacers along with the tools of thisinvention allow the spacers to be packed closely together becausevirtually no clearance is required for the insertion tool. The openmouth also allows the chambers to be packed after the spacer isimplanted. This is greatly enhanced when one of the arms is truncated,leaving a channel from outside the disc space to the chamber as shown inFIG. 10.

It has been found that certain dimensions are preferred when a spacer ofthis invention is a bone dowel. For the substantially “C”-shapedchamber, 530, a regular or irregular hole having a diameter no greaterthan about 0.551″ (14 mm) is preferred with a minimum wall thickness 570at the root of the thread of preferably no less than about 5 mm. Thoseskilled in the art will recognize that the foregoing specifics, whilepreferable, may be modified depending on the particular surgicalrequirement of a given application.

In another specific embodiment, depicted in FIGS. 35-38, the diameter D1of the dowel is 18 mm and the length L1 is 36 mm. In this specificembodiment, the length L2 of the solid side is shorter than the lengthof the open side L1 due to the natural curve of the bone. The shorterlength L2 is preferably at least 30% of the longer length L1. The lengthof the truncated arm is preferably between about 50-85% of the diameterof the dowel D1. In this embodiment, the insertion end of the dowelincludes a flattened portion F1. The length of the flattened portion F1is preferably at least 70% of the diameter of the dowel D1. As bestshown in FIG. 36, the depth E1 a, E1 b, E2 a, E2 b of the end-caps orinsertion end and tool engaging ends of the dowel are preferably atleast about 3 mm. The depth of the bevel B2 of the threads is preferably1 mm while the bevel angle B1 is preferably about 45 degrees. The depthof the drive slot C2 is preferably about 1.5 mm deep and the width C1 isabout 5.5 mm. The diameter D2 of the tapped instrument attachment holeis about 3.3 mm with T5 indicating the tapped thread.

Various surface feature configurations are contemplated by thisinvention. Referring now to FIG. 38, a detail of the thread of oneembodiment is provided. The thread pitch T1 is about 2.5 mm. The lengthT2 of the top of each tooth of the thread is about 0.6 mm, the depth T4of the thread is about 1 mm and the width T3 of the thread at the threadroot is about 0.8 mm. The outer thread angle A3 is about 60 degrees inthis embodiment. FIG. 39 shows a detail of a portion of a threaded dowelof another embodiment which has ten right handed threads per inch at ahelix angle at the root diameter of about 2.8892°. In this specificembodiment, the pitch T1′ is 0.100″; the thread angle A1′ is 60°; thethread crest width T2′ is 0.025″; the thread height T4′ is 0.039″; andthe radius of the various thread angle as it changes R is typicallyabout 0.010″.

While the foregoing description discloses specific aspects of thisinvention, those skilled in the art will recognize that any of a numberof variations on the basic theme disclosed herein can be made. It iscontemplated that the spacers of this invention can be formed of anysuitable biocompatible material, including metals, ceramics, polymers,composites, alloys and the like. Some embodiments include titanium,stainless steel, and Hedrocel*. Thus, for example, differing shapes canbe made from the diaphysis of various bones and could be used for otherorthopaedic purposes than vertebral fusions. In addition, any of anumber of known bone treatments can be applied to the dowel of thisinvention to alter its properties. For example, the methods disclosed inU.S. Pat. Nos. 4,627,853; 5,053,049; 5,306,303 and 5,171,279 can beadapted and applied to the invention disclosed herein. Accordingly thedisclosures of those patents is herein incorporated by reference forthis purpose.

Having described the dowel of this invention, its mode of manufactureand use, the following specific examples are provided by way of furtherexemplification and should not be interpreted as limiting on the scopeof the invention herein disclosed and claimed.

EXAMPLES Example 1 Torsional Testing of “C”-Shaped Dowel

The C-shaped dowel of this invention was tested and the followingmeasurements made of the dowel's ability to withstand insertionaltorque. The data presented here are for the 16 mm dowel. However,similar results are expected for other lengths of the dowel of thisinvention. For each dowel, a measured torque is applied to the dowel asit is maintained in a stationary position. For biological insertion ofdowels, torques no higher than about 1 newton-meter are expected. Thevarious dimensions measured in the following table correspond to thedimension shown in FIGS. 35-38:

Diam. OD ID Height Calc. % diff. (mm) (mm) (mm) (mm) Thick- Meas.*Failure Failure Sample D1 W1 W1* H** ness*** Calc. Torque Type 1 15.85.1 4.6 13.2 4.0 15 4.00 s. wall 2 15.8 5.5 4.8 13.2 4.0 19 3.5 s. wall3 15.9 6.2 5.3 13.4 4.3 25 3.89 slot 4 15.9 7.0 6.3 14.1 5.1 23 4.95slot 5 15.6 5.8 5.4 13.6 4.5 21 5.2 s. wall 6 15.8 5.5 4.9 13.1 4.0 244.36 s. wall 7 15.7 5.8 5.4 13.4 4.3 27 4.00 slot W1*= W1-T4; H**= seeH1-H4, FIG. 16; calc. thickness***= theoretical calculations based onsidewall height, H

From these data, it is clear that dowels of this invention are able towithstand considerably more than the 1 newton-meter of torque requiredto insert the dowel in physiological situations. From theoreticalcalculations based on the sidewall height, the difference between thecalculated sidewall thickness and the measured thickness was found tobe, on average, about 22%, leading to the conclusion that onlyapproximately 22% the measured thickness is cancellous bone, and thesubstantial majority of the bone is cortical bone.

Example 2 Compression Testing

The “C”-shaped dowel of this invention was compressively tested and theload to failure was measured. It is anticipated that loads no higherthan about 10,000 newtons are likely to be experienced in-place in thevertebral column. Compression testing of several different “C”-shapeddowels of this invention indicated that dowels of this invention surviveaxial compression loads significantly higher than the 15,000 newtonthreshold:

Failure Avg Avg Avg Mass Load # Thread D1 L1 E2a E2b E2 E1a E1b E1 g (N)1 no 15.9 25.5 5.3 4.7 5.0 3.9 4.4 4.2 4.193 4372 2 yes 15.9 23.7 5.15.1 5.1 4.2 5.0 4.6 4.073 13502 3 no 15.9 23.7 4.8 5.3 5.1 3.8 2.6 3.34.035 13748 4 yes 15.9 22.5 7.1 7.0 7.1 7.0 5.4 6.2 5.075 20940 5 poor16.0 23.4 5.6 5.4 5.5 5.8 6.2 6.0 4.986 22420 6 yes 15.7 26.1 7.1 7.17.1 8.4 8.6 8.5 5.331 24500 7 yes 16.8 23.8 5.4 5.0 5.2 6.0 6.0 6.93.928 14389 8 yes 17.6 22.4 4.8 5.5 5.2 5.8 4.6 5.2 5.448 16730 9 poor16.9 22.2 6.7 5.2 8.0 6.4 4.7 5.1 5.228 19576 10 poor 17.9 28.3 7.8 7.27.5 7.6 7.2 7.4 6.201 20606 11 yes 17.9 21.2 4.9 6.8 5.9 4.5 4.4 4.55.654 21461 12 yes 17.8 23.6 6.6 6.3 6.5 6.0 5.4 5.7 5.706 23971 13 yes19.9 25.6 6.3 6.6 6.5 6.4 6.4 6.4 7.915 24761

The mean load to failure of these dowels is 18544 newtons, indicatingthat on average, more dowels can withstand 15000 newtons axial pressurethan not. These data also indicate the need for diligent quality controlto eliminate dowels that do not withstand minimal axial compressionloads from being implanted.

Example 3 Cervical Fusion Using “C”-shaped Dowel

Preoperative Diagnosis. Ruptured cervical disc and spondylosis C5-6.

Operative Procedure. Anterior cervical discectomy and fusion C5-6.

After satisfactory general endotracheal anesthesia in the supineposition, the patient is prepped and draped in the routine fusion.Incision is made in the skin length of the neck and carried through theplatysma muscle. Dissection is carried down to expose the anteriorvertebral column and the appropriate space identified by x-ray.Discectomy and foraminotomy are then performed and there is found acentral, extruded fragment of disc toward the right side. When adequatedecompression is achieved, a “C”-shaped dowel is cut from bone bankfibular and counter-sunk between the vertebral bodies to afforddistraction. The wound is then irrigated with Bacitracin and closed inlayers with Dexon and sterile strips.

Postoperative evaluation and subsequent patient monitoring revealssuccessful operative outcome and good vertebral fusion.

It should be understood that the example and embodiments describedherein are for illustrative purposes only and that various modificationsor changes in light thereof will be suggested to persons skilled in theart and are to be included within the spirit and purview of thisapplication and the scope of the appended claims.

1. An intervertebral fusion spacer for engagement within an intervertebral space between adjacent vertebrae, comprising: a spacer body defining a spacer height, a spacer width and a spacer length extending along a longitudinal axis, said spacer body including a channel extending there through along said spacer height and arranged along a second axis substantially perpendicular to said longitudinal axis, said channel opening laterally onto an outer surface of said spacer body in a direction transverse to said second axis and defining a mouth opening into said channel.
 2. The intervertebral fusion spacer of claim 1, wherein said channel is defined by a concave inner surface extending about said second axis and opening onto said outer surface.
 3. The intervertebral fusion spacer of claim 2, wherein said concave inner surface is substantially semi-circular.
 4. The intervertebral fusion spacer of claim 2, wherein said channel is C-shaped.
 5. The intervertebral fusion spacer of claim 1, wherein said spacer body comprises a C-shaped wall extending about said channel.
 6. The intervertebral fusion spacer of claim 1, wherein said spacer body includes a first arm extending along said spacer width and an opposite second arm extending along said spacer width, said first arm offset from said second arm in a direction along said longitudinal axis and defining said channel therebetween with end portions of said first and second arms defining said mouth.
 7. The intervertebral fusion spacer of claim 1, wherein said spacer body has a generally circular outer cross section extending along said longitudinal axis.
 8. The intervertebral fusion spacer of claim 7, wherein said spacer body is externally threaded and defines thread turns extending about said longitudinal axis; and wherein said channel interrupts at least some of said thread turns.
 9. The intervertebral fusion spacer of claim 7, wherein said spacer body includes upper and lower vertebral engaging surfaces defining upper and lower flattened portions with said channel opening onto said upper and lower flattened portions.
 10. The intervertebral fusion spacer of claim 1, wherein said spacer body includes opposite first and second ends arranged along said longitudinal axis, said spacer body including a side wall having upper and lower flattened portions that define a reduced height of said sidewall and said first and second opposite ends of said spacer body; and wherein said channel opens onto said upper and lower flattened portions.
 11. The intervertebral fusion spacer of claim 1, further comprising an osteogenic material positioned within said channel.
 12. The intervertebral fusion spacer of claim 1, wherein said spacer body is formed of a material selected from the group consisting of a metal, a polymer and a ceramic.
 13. A system for fusion of adjacent vertebrae, comprising: first and second ones of the intervertebral fusion spacer of claim 1; wherein said first and second intervertebral fusion spacers are position able within the intervertebal space between the adjacent vertebrae; and wherein said mouth of said first intervertebral fusion spacer directly opposes said mouth Of said second intervertebral fusion spacer to define an elongated compartment therebetween for receipt of an estrogenic material.
 14. An intervertebral fusion spacer for engagement within an intervertebral space between adjacent vertebrae, comprising: a spacer body defining a spacer height, a spacer width and a spacer length extending along a longitudinal axis, said spacer body including a first arm extending along said spacer width and an opposite second arm extending along said spacer width, said first arm offset from said second arm in a direction along said longitudinal axis and defining a channel therebetween, said channel extending entirely through said spacer body along said spacer height and opening laterally onto an outer surface of said spacer body with end portions of said first and second arms forming a mouth opening into said channel.
 15. The intervertebral fusion spacer of claim 14, wherein said channel is arranged along a second axis substantially perpendicular to said longitudinal axis; and wherein said mouth opens in a direction transverse to said second axis.
 16. The intervertebral fusion spacer of claim 14, wherein said channel is substantially semi-circular.
 17. The intervertebral fusion spacer of claim 14, wherein said channel is C-shaped.
 18. The intervertebral fusion spacer of claim 14, wherein said spacer body comprises a C-shaped body extending about said channel.
 19. The intervertebral fusion spacer of claim 14, wherein said spacer body has a generally circular outer cross section extending along said longitudinal axis.
 20. The intervertebral fusion spacer of claim 19, wherein said spacer body is externally threaded and defines thread turns extending about said longitudinal axis; and wherein said channel interrupts at least some of said thread turns.
 21. The intervertebral fusion spacer of claim 19, wherein said spacer body includes upper and lower vertebral engaging surfaces defining upper and lower flattened portions with said channel opening onto said upper and lower flattened portions.
 22. The intervertebral fusion spacer of claim 14, wherein said spacer body includes threaded bone engaging portions configured to engage the adjacent vertebrae.
 23. The intervertebral fusion spacer of claim 14, wherein said spacer body includes opposite first and second ends arranged along said longitudinal axis, said spacer body including a side wall having upper and lower flattened portions that define a reduced height of said sidewall and said first and second opposite ends of said spacer body; and wherein said channel opens onto said upper and lower flattened portions.
 24. The intervertebral fusion spacer of claim 14, further comprising an osteogenic material positioned within said channel.
 25. The intervertebral fusion spacer of claim 14, wherein said spacer body is formed of a material selected from the group consisting of a metal, a polymer, a ceramic and a composite. 